- AQUIPTA® (atogepant) is the first
and only once-daily oral calcitonin gene-related peptide (CGRP)
receptor antagonist (gepant) in the European Union (EU) approved
for the prophylaxis of migraine in adults who have four or more
migraine days per month
- Approval is based on two pivotal Phase 3 studies that
demonstrated statistically significant reduction in mean monthly
migraine days with AQUIPTA compared to placebo in adult patients
with both chronic and episodic migraine
- The approval expands AbbVie's portfolio of
therapies for adult patients in the EU across migraine
frequencies, including episodic and chronic
migraine
NORTH
CHICAGO, Ill., Aug. 17,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that the European Commission has approved
AQUIPTA® (atogepant) for the prophylaxis of
migraine in adults who have four or more migraine days per month.
The approval makes AQUIPTA the first and only once-daily oral
calcitonin gene-related peptide (CGRP) receptor antagonist (gepant)
treatment in the European Union for the preventive treatment of
both chronic and episodic migraine.
Chronic migraine is characterized by 15 or more headache days
per month and at least eight migraine days, while episodic migraine
refers to people with migraine who have less than 15 headache days
per month.1 People living with migraine may experience
frequent disabling attacks that prevent them from performing daily
activities and can significantly affect their quality of
life.2 This debilitating disease also imposes both a
social and financial burden for people living with migraine and
health care systems.3 In Europe, migraine is estimated to cost the
economy €50 billion annually due to reduced productivity and
workdays lost.4
"The European Commission approval of AQUIPTA is a significant
milestone for people suffering from four or more migraine days per
month as it provides a once-daily treatment option that can reduce
the number of migraine days and the associated pain they
experience," said Roopal Thakkar,
SVP, Development and Regulatory Affairs, Chief Medical Officer,
AbbVie. "With this approval, AbbVie can help meet additional
migraine patient needs through our enhanced portfolio of treatment
options across migraine frequencies, including episodic and chronic
migraine."
The approval of AQUIPTA is supported by data from two
pivotal Phase 3 studies, PROGRESS and ADVANCE, which evaluated 60
mg once-daily (QD) AQUIPTA in adult patients with chronic migraine
and episodic migraine, respectively. Both studies met their primary
endpoint of a statistically significant reduction in mean monthly
migraine days (MMDs), compared to placebo across the 12-week
treatment period. Additionally, statistically significant
improvements were seen in all secondary endpoints with AQUIPTA 60
mg QD, with a key secondary endpoint measuring the proportion of
patients that achieved at least a 50% reduction in MMDs across the
12-week treatment period.5,6
In the PROGRESS study, the changes from baseline in MMDs was a
reduction of 6.8 days for AQUIPTA 60 mg QD and a reduction of
5.1 days for placebo (p=0.0024). The study demonstrated that 40% of
patients treated with AQUIPTA 60 mg QD achieved at least a 50%
reduction in MMDs, compared to 27% of patients in the placebo arm
(p=0.0024).5 In the ADVANCE study, the changes from
baseline in MMDs was a reduction of 4.1 days for AQUIPTA 60 mg QD
and a reduction of 2.5 days for placebo (p≤0.001). The study also
demonstrated that 59% of patients treated with AQUIPTA 60 mg QD
achieved at least a 50% reduction in MMDs, compared to 29% of
patients in the placebo arm (p≤0.0001).6
In both studies, AQUIPTA 60 mg QD was well tolerated and the
most common adverse events were constipation (8%), nausea (9%) and
fatigue (5%). The adverse drug reaction most commonly leading to
study discontinuation was nausea (0.4%).5,6
"Migraine is a neurological disease that causes recurrent pain
and other migraine-associated symptoms, with attacks that can last
several hours to days, leading to missed life opportunities," said
Prof. Patricia Pozo-Rosich, MD, PhD, Head of Neurology
Section, Vall d'Hebron Hospital and Institute of
Research, Spain. "The pivotal Phase 3 studies demonstrated
AQUIPTA provides significant and sustained reduction of mean
monthly migraine days. This allows people to experience relief with
a simple to take once-daily tablet, including those who have had an
insufficient response to prior preventative migraine
treatments."
Atogepant is approved in the United
States for both chronic and episodic migraine and in
Canada for episodic migraine under
the brand name QULIPTA®.
About the Phase 3 PROGRESS Clinical
Trial5
The pivotal Phase 3 PROGRESS study
evaluated the safety, tolerability, and efficacy of oral atogepant
for the prophylaxis of chronic migraine compared with placebo. The
study included 778 patients with a diagnosis of chronic
migraine for at least one year, with greater or equal to 15
headache days and at least eight migraine days in the 28 days
prior. Patients were randomized into one of three treatment groups
receiving 60 mg QD of atogepant, 30 mg twice daily of atogepant, or
placebo. The primary endpoint measured the reduction from baseline
in mean MMDs compared to placebo for 60 mg QD across a 12-week
treatment period (p=0.0024). The overall safety profile observed in
the Phase 3 PROGRESS study was consistent with safety findings
observed in previous studies. The most common adverse events
reported with a frequency greater than or equal to 5% in the
atogepant 60 mg QD arm were constipation (10% vs. 3% for placebo),
nausea (10% vs. 4% for placebo), abdominal pain (10% vs. 1% for
placebo), diarrhea (10% vs. 2% for placebo), and insomnia (10% vs.
2% for placebo). Most of the events of constipation and nausea were
mild or moderate in severity and did not lead to study
discontinuation.
Additional key secondary endpoints included change from baseline
in mean monthly headache days (MHDs), change from baseline in mean
monthly acute-medication use days, proportion of participants with
at least a 50% reduction in MMDs across the 12-week treatment
period, and several patient-reported outcome measures
assessing functioning.
About the Phase 3 ADVANCE Clinical
Trial6
The pivotal Phase 3 ADVANCE study
evaluated the efficacy, safety, and tolerability of oral atogepant
for the prevention of migraine in those with 4 to 14 migraine days
per month. A total of 910 patients were randomized to one of four
treatment groups evaluating 10 mg, 30 mg, or 60 mg of atogepant QD,
or placebo. The primary endpoint was change from baseline in mean
MMDs compared to placebo for 60 mg QD across a 12-week treatment
period (p<0.001). The study demonstrated that treatment
with atogepant 60 mg QD resulted in statistically significant
improvements in all the primary and secondary endpoints. The most
common adverse events reported with a frequency greater than or
equal to 5% in the atogepant 60 mg QD arm were constipation (6.9%
vs. 0.5% for placebo) and nausea (6.1% vs. 1.8% for
placebo). Most of the events of constipation and nausea were
mild or moderate in severity and did not lead to study
discontinuation.
Additional key secondary endpoints included change from baseline
in MHDs, mean monthly acute-medication use days, proportion of
patients achieving at least a 50% reduction from baseline in MMDs
across the 12-week treatment period, and several patient-reported
outcome measures assessing functioning.
About
AQUIPTA® (atogepant)
Atogepant is an orally administered, CGRP receptor antagonist
specifically developed for the preventive treatment of migraine in
adults who have four or more migraine days per month. CGRP and its
receptors are expressed in regions of the nervous system associated
with migraine pathophysiology. Studies have shown that CGRP levels
are elevated during migraine attacks and selective CGRP receptor
antagonists confer clinical benefit in migraine.
EU Indications and Important Safety Information about
AQUIPTA®▼(atogepant)
Indication
AQUIPTA (atogepant) is indicated for
prophylaxis of migraine in adults who have at least 4 migraine days
per month.
Important Safety Information
Contraindications
AQUIPTA is contraindicated in
patients with hypersensitivity to the active substance or to any of
the excipients.
Special warnings and precautions for use
AQUIPTA
is not recommended in patients with severe hepatic impairment.
Fertility, pregnancy and lactation
AQUIPTA is not
recommended during pregnancy and in women of childbearing potential
not using contraception.
Effects on ability to drive and use machines
AQUIPTA
has no or negligible influence on the ability to drive and use
machines. However, it may cause somnolence in some patients.
Patients should exercise caution before driving or using machinery
until they are reasonably certain that AQUIPTA does not adversely
affect performance.
Adverse reactions
The most commonly reported adverse
drug reactions during AQUIPTA studies were nausea 9%, constipation
8%, and fatigue/somnolence 5%. Most of the reactions were mild or
moderate in severity. The adverse drug reaction that most commonly
led to discontinuation was nausea 0.4%.
This is not a complete summary of all safety information. See
AQUIPTA full summary of product characteristics (SmPC) at
www.ema.europa.eu.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie in Neuroscience
At AbbVie, our
commitment to preserving personhood of people around the world
living with neurological and psychiatric disorders is unwavering.
With more than three decades of experience in neuroscience, we are
providing meaningful treatment options today and advancing
innovation for the future. AbbVie's Neuroscience portfolio consists
of approved treatments in neurological conditions, including
migraine, movement disorders, and psychiatric disorders, along with
a robust pipeline of transformative therapies. We have made a
strong investment in research and are committed to building a
deeper understanding of neurological and psychiatric disorders.
Every challenge makes us more determined and drives us to discover
and deliver advancements for those impacted by these conditions,
their care partners, and clinicians. For more information, visit
www.abbvie.com.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions that solve serious health issues today and address
the medical challenges of tomorrow. We strive to have a remarkable
impact on people's lives across several key therapeutic areas –
immunology, oncology, neuroscience, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions and uses of future
or conditional verbs, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2022 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
References
1 Katsarava Z, Buse DC, Manack
AN, Lipton RB. Defining the differences between episodic migraine
and chronic migraine. Curr Pain Headache Rep. 2012; 16(1):
86–92.
2 Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality
of life impairment, disability and economic burden associated with
chronic daily headache, focusing on chronic migraine with or
without medication overuse: a systematic review. Cephalalgia.
2011;31:837-850.
3 Messali A, Sanderson JC, Blumenfeld AM, et al. Direct
and indirect costs of chronic and episodic migraine in the United States: a web-based survey.
Headache. 2016;56:306-322.
4 Rethinking Migraine in times of COVID-19. European
Brain Council. 2023. Available
at: https://www.braincouncil.eu/projects/rethinking-migraine/.
Accessed August 11, 2023.
5 Pozo-Rosich P., et al.
The Lancet. Atogepant for the Preventive Treatment of Chronic
Migraine (PROGRESS). 2023; DOI: 10.1016/S0140-6736(23)01049-8.
6 Ailani J, et al. NEJM. Atogepant for the Preventive
Treatment of Migraine. 2021; 385:695-706. DOI:
10.1056/NEJMoa2035908.
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